Histoplasma capsulatum var. capsulatum histoplasmosis is the leading cause of acquired immunodeficiency syndrome (AIDS) and death in French Guiana and probably in the Amazon. The diagnosis of this disease requires invasives procedures, laboratory performance, and delays up to several weeks. The Mycotic Diseases Branch of the Centers for Disease Control and Prevention (CDC) has established a rapid, sensitive and specific ELISA test for blood and urine samples that looks interesting in endemic areas, particularly in developing countries. The study aims to measure the proportion of HIV-infected patients hospitalized or in outpatient awaiting hospitalization for a suspicion of infectious syndrome whose serum and/or urinary antigen detection tests are positive for Histoplasma capsulatum var. capsulatum.

Histoplasmosis in the Guiana Shield and the French West Indies: Evaluating Prevalence in HIV + Patients With a Rapid Diagnostic Test Using an ELISA Capture Method for the Detection of Histoplasma Antigens in Blood and Urine.

Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

Primary Outcome Measures:

Proportion of HIV-infected patients hospitalized or in outpatient awaiting hospitalization for a suspicion of infectious syndrome whose serum and/or urinary antigen detection tests are positive for Histoplasma capsulatum var. capsulatum. [ Time Frame: At the time of inclusion (baseline) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Sensitivity of the ELISA test on urine and blood specimens [ Time Frame: At the time of inclusion (baseline) ] [ Designated as safety issue: No ]

Sensibility of the ELISA test on urine and blood specimens [ Time Frame: At the time of inclusion (baseline) ] [ Designated as safety issue: No ]

Negative predictive value of the ELISA test on urine and blood specimens [ Time Frame: At the time of inclusion (baseline) ] [ Designated as safety issue: No ]

Comparison of the distribution of Histoplasma antigen concentrations in urine and serum specimens according to severity of cases of histoplasmosis due to Histoplasma capsulatum var. capsulatum [ Time Frame: At the time of inclusion (baseline) ] [ Designated as safety issue: No ]

Comparison of the socio-demographic, clinical, paraclinical and therapeutic characteristics according to severity of cases of histoplasmosis due to Histoplasma capsulatum var. capsulatum [ Time Frame: 30 days or 90 days after inclusion ] [ Designated as safety issue: No ]

Comparison of the factors for environmental exposure to Histoplasma capsulatum var capsulatum between patients with a positive ELISA test and/or fungal culture for histoplasmosis and those who tested negative for histoplasmosis [ Time Frame: At the time of inclusion ] [ Designated as safety issue: No ]

Frequency of histoplasmosis compared to the other main diagnoses according to three sets of comparisons: positive ELISA test and positive fungal culture; positive ELISA test and negative fungal culture; negative ELISA test and positive fungal culture [ Time Frame: 90 days after inclusion ] [ Designated as safety issue: No ]

Comparison of the socio-demographic, clinical, paraclinical, therapeutic and survival outcome characteristics of cases of histoplasmosis compared to those who tested negative for histoplasmosis [ Time Frame: 90 days after inclusion ] [ Designated as safety issue: No ]

Identify the prognostic factors for short-term unfavourable progression of cases of histoplasmosis due to Histoplasma capsulatum var. capsulatum confirmed by ELISA test and/or by fungal culture [ Time Frame: 30 days and 90 days after inclusion ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Urine, serum and Histoplasma capsulatum var. capsulatum strains

Estimated Enrollment:

727

Study Start Date:

August 2013

Estimated Study Completion Date:

October 2016

Primary Completion Date:

July 2014 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population

Adult (aged 18 or over), seen while hospitalized or in outpatient awaiting hospitalization, HIV1 or HIV2 infection confirmed by techniques validated in France and in Suriname, either before the episode considered, or discovered concomitantly, and presenting at least one of the three followings items: an alteration of their general condition (with a grade 1 according to the WHO Performance Status scale) and/or a fever and/or symptoms suggestive of an infectious syndrome.

Criteria

Inclusion Criteria:

Adult (aged 18 or over).

Patient seen while hospitalized or in outpatient awaiting hospitalization.

HIV1 or HIV2 infection confirmed by techniques validated in France and in Suriname, either before the episode considered, or discovered concomitantly.

Patient presenting at least one of the three followings items: an alteration of their general condition (with a grade 1 according to the WHO Performance Status scale) and/or a fever and/or symptoms suggestive of an infectious syndrome.

Medical prescription for the collection of blood and urine specimens to test for an infectious agent within 7 days following admission to the hospital.

Written consent to participate in the study obtained.

Exclusion Criteria:

Refusal to participate in the study.

Patient in a critical condition that doesn't allow physicians to get an informed consent without a legal representative to represent him and sign a consent form for the patient participation in the study.

Ongoing antifungal treatment or antifungal treatment stopped during the month preceding the inclusion date (topic antifungal therapy not considered at this point).

Patient in detention at the time of admission to the hospital.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01884779

Locations

France

Pointe-à-Pitre University Hospital

Pointe-à-Pitre, Guadeloupe, France, 97159

Cayenne General Hospital

Cayenne, Guyane, France, 97306

Western French Guiana Hospital

Saint-Laurent-du-Maroni, Guyane, France, 97320

Fort-de-France University Hospital

Fort-de-France, Martinique, France, 97261

Suriname

's Lands Hospital

Paramaribo, Suriname

Academisch Ziekenhuis Paramaribo Hospital

Paramaribo, Suriname

Diakonessenhuis hospital

Paramaribo, Suriname

Sponsors and Collaborators

French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Investigators

Study Chair:

Mathieu NACHER, MD, PhD

CIE 802 Inserm / DGOS

Study Chair:

Stephen G VREDEN, MD, PhD

Foundation for Scientific Research Suriname (SWOS)

More Information

Responsible Party:

French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)